Mitigating false messaging in leadless dual-chamber pacing systems and other IMD systems

ABSTRACT

Implantable medical devices (IMDs), and methods for use therewith, reduce how often an IMD accepts false messages. Such a method can include receiving a message and performing error detection and correction on the message. Such a method can also include determining a quality measure indicative of a quality of the message and/or a quality of a channel over which the message was received, and determining whether to reject the message based on the quality measure.

FIELD OF TECHNOLOGY

Embodiments described herein generally relate to methods and systems forcommunication between implantable medical devices, or communicatingbetween a non-implantable device and an implantable medical device.

BACKGROUND

Implantable medical devices and systems often rely on propercommunications to operate correctly. For example, in a dual chamberpacemaker system, implant-to-implant (i2i) communications are criticalfor proper synchronization and operation of the system. However, noisemay cause one or more devices of such a system to falsely detect an i2imessage and inappropriately respond thereto. For a more specificexample, noise may cause a ventricular leadless pacemaker (LP) tofalsely detect a message from an atrial LP, which then could trigger theventricular LP to pace at an inappropriate high-rate, and moregenerally, at inappropriate times.

Such messages may include redundant data for error detection andcorrection. However, due to the desire to keep the power consumptionlow, the messaging and/or error correction and detection scheme may besimple and false messages may still get through.

SUMMARY

Implantable medical devices (IMDs), and methods for use therewith,reduce how often an IMD accepts false messages. Such a method caninclude receiving a message and performing error detection andcorrection on the message. Such a method can also include determining aquality measure indicative of at least one of a quality of the messageor a quality of a channel over which the message was received, anddetermining whether to reject the message based on the quality measure.

Where the quality measure is indicative of a quality of the message, thequality of the message can be based on results of the error detectionand correction. More specifically, the results of the error detectionand correction can specify one of at least two different levels ofmessage quality. In such embodiments, a method can include mapping theresults of the error detection and correction to one of at least twodifferent numbers, adjusting an average message quality based on thenumber, and comparing the average message quality to one or morethresholds. The method can further include determining whether to rejectthe message based on results of the comparing the average messagequality to the one or more thresholds. The mapping the results of theerror detection and correction to one number of at least two differentnumbers can include mapping the results of the error detection andcorrection to a first number if the results indicated the message wascleanly received without any correcting being needed, mapping theresults of the error detection and correction to a second number that isless than the first number if the results indicated the message wascorrected, and mapping the results of the error detection and correctionto a third number that is less than the second number if the resultsindicated the message was uncorrectable. In such an embodiment, theaverage message quality can be adjusted using an equationQ=(1−1/b)*Q+N*(1/b), where Q is the average message quality, N is thenumber to which the results of the error detection and correction wasmapped, and b is a time constant parameter that controls a rate ofchange.

In accordance with certain embodiments, the quality measure is based onwhether an amplitude or power of a received signal including the messageis within an expected amplitude or power range. Alternatively, oradditionally, the quality measure can be based on whether a timing ofthe message is within an expected timing range.

In accordance with certain embodiments, the determining whether toreject the message includes determining that the message should berejected if the quality measure is below a corresponding lowerthreshold, determining that the message should not be rejected if thequality measure is above a corresponding upper threshold, and if thequality measure is between the corresponding lower and upper thresholds,then determining that the message should be rejected if the precedingmessage was rejected, and determining that the message should not berejected if the preceding message was not rejected.

In accordance with certain embodiments, where the quality measure isindicative of the quality of the channel over which the message wasreceived, a method can include measuring noise associated with thechannel over which the message was received, and determining the qualityof the channel over which the message was received based on the measurednoise associated with the channel.

In accordance with certain embodiments, an IMD includes at least onereceiver configured to receive messages, and a processor and/orcontroller. The processor and/or controller can be configured to performerror detection and correction on a message received by the at least onereceiver, determine a quality measure indicative of at least one of aquality of the message or a quality of a channel over which the messagewas received, and determine whether to reject the message based on thequality measure.

In accordance with certain embodiments, the IMD is a leadless pacemaker(LP) configured to be implanted in a ventricle of a patient's heart andconfigured to selectively deliver ventricular pacing pules. The messagescan be received from another LP that is configured to be implanted in anatrium of a patient's heart and configured to at least one of senseintrinsic atrial depolarizations or selectively deliver atrial pacingpulses. The messages can be indicative of when the other LP sensed anintrinsic atrial depolarization or delivered an atrial pacing pulse.Such a message, if accepted, can be used to trigger an atrioventricularinterval (AVI) timer of the LP.

This summary is not intended to be a complete description of theembodiments of the present technology. Other features and advantages ofthe embodiments of the present technology will appear from the followingdescription in which the preferred embodiments have been set forth indetail, in conjunction with the accompanying drawings and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the present technology relating to both structure andmethod of operation may best be understood by referring to the followingdescription and accompanying drawings, in which similar referencecharacters denote similar elements throughout the several views:

FIG. 1 illustrates a system formed in accordance with certainembodiments herein as implanted in a heart.

FIG. 2 is a block diagram of a single LP in accordance with certainembodiments herein.

FIG. 3 illustrates an LP in accordance with certain embodiments herein.

FIG. 4 is a timing diagram demonstrating one embodiment of implant toimplant (i2i) communication for a paced event.

FIG. 5 is a timing diagram demonstrating one embodiment of i2icommunication for a sensed event.

FIGS. 6A-6D are high level flow diagrams that are used to summarizemethods according to certain embodiments of the present technology.

FIG. 7 is a timing diagram illustrating an exemplary message interval,an exemplary message window and an exemplary window positioninginterval.

FIG. 8 shows a block diagram of one embodiment of an LP that isimplanted into the patient as part of the implantable cardiac system inaccordance with certain embodiments herein.

DETAILED DESCRIPTION

Certain embodiments of the present technology related to implantablemedical devices (IMDs), and methods for use therewith, that reduce howoften false messages are accepted. Such a method can include receiving amessage and measuring a message interval indicative of a length of timebetween when the message was received and when a preceding message wasreceived. The method can also include determining, based on the measuredmessage interval, whether the message was received within the messagewindow, and determining whether to reject the message based on resultsthereof. The method can also include adjusting a temporal position ofthe message window based on the measured message interval. A method canadditionally or alternatively include determining a quality measureindicative of a quality of the message and/or a quality of a channelover which the message was received, and determining whether to rejectthe message based on the quality measure.

Before providing addition details of the specific embodiments of thepresent technology mentioned above, an exemplary system in whichembodiments of the present technology can be used with first bedescribed with reference to FIGS. 1-5. More specifically, FIGS. 1-5 willbe used to describe an exemplary cardiac pacing system, wherein pacingand sensing operations can be performed by multiple medical devices,which may include one or more leadless cardiac pacemakers, an ICD, suchas a subcutaneous-ICD, and/or a programmer reliably and safelycoordinate pacing and/or sensing operations.

FIG. 1 illustrates a system 100 that is configured to be implanted in aheart 101. The system 100 comprises two or more leadless pacemakers(LPs) 102 and 104 located in different chambers of the heart. LP 102 islocated in a right atrium, while LP 104 is located in a right ventricle.LPs 102 and 104 communicate with one another to inform one another ofvarious local physiologic activities, such as local intrinsic events,local paced events and the like. LPs 102 and 104 may be constructed in asimilar manner, but operate differently based upon which chamber LP 102or 104 is located.

In some embodiments, LPs 102 and 104 communicate with one another, withan ICD 106, and with an external device (programmer) 109 throughwireless transceivers, communication coils and antenna, and/or byconductive communication through the same electrodes as used for sensingand/or delivery of pacing therapy. When conductive communication ismaintained through the same electrodes as used for pacing, the system100 may omit an antenna or telemetry coil in one or more of LPs 102 and104.

In some embodiments, one or more leadless cardiac pacemakers 102 and 104can be co-implanted with the implantable cardioverter-defibrillator(ICD) 106. Each leadless cardiac pacemaker 102, 104 uses two or moreelectrodes located within, on, or within a few centimeters of thehousing of the pacemaker, for pacing and sensing at the cardiac chamber,for bidirectional communication with one another, with the programmer109, and the ICD 106.

In accordance with certain embodiments, methods are provided forcoordinating operation between leadless pacemakers (LPs) located indifferent chambers of the heart. The methods configure a local LP toreceive communications from a remote LP through conductivecommunication.

While the methods and systems described herein include examplesprimarily in the context of LPs, it is understood that the methods andsystems herein may be utilized with various other external and implanteddevices. By way of example, the methods and systems may coordinateoperation between various implantable medical devices (IMDs) implantedin a human, not just LPs. The methods and systems comprise configuring afirst IMD to receive communications from at least a second IMD throughconductive communication over at least a first channel. It should alsobe understood that the methods and systems may coordinate operationbetween multiple IMDs, and are not limited to coordinate operationbetween just a first and second IMD. The methods and systems may also beused to coordinate operation of two or more IMDs implanted within thesame chamber that may be the same type of IMD or may be different typesof IMDs. The methods and systems may also be used to coordinateoperation of two or more IMDs in a system comprising at least one IMDimplanted but not within a heart chamber, e.g., epicardially,transmurally, intravascularly (e.g., coronary sinus), subcutaneously(e.g., S-ICD), etc.

Referring to FIG. 2, a pictorial diagram shows an embodiment forportions of the electronics within LP 102, 104 configured to provideconducted communication through the sensing/pacing electrode. One ormore of LPs 102 and 104 comprise at least two leadless electrodes 108configured for delivering cardiac pacing pulses, sensing evoked and/ornatural cardiac electrical signals, and uni-directional or bidirectionalcommunication.

LP 102, 104 includes a transmitter 118 and first and second receivers120 and 122 that collectively define separate first and secondcommunication channels 105 and 107 (FIG. 1), (among other things)between LPs 102 and 104. Although first and second receivers 120 and 122are depicted, in other embodiments, LP 102, 104 may only include firstreceiver 120, or may include additional receivers other than first andsecond receivers 120 and 122. LP 102, 104 may only also include one ormore transmitters in addition to transmitter 118. In certainembodiments, LPs 102 and 104 may communicate over more than just firstand second communication channels 105 and 107. In certain embodiments,LPs 102 and 104 may communicate over one common communication channel105. The transmitter 118 and receiver(s) 120, 122 may each utilize aseparate antenna or may utilize a common antenna 128. Optionally, LPs102 and 104 communicate conductively over a common physical channel viathe same electrodes 108 that are also used to deliver pacing pulses.Usage of the electrodes 108 for communication enables the one or moreleadless cardiac pacemakers 102 and 104 for antenna-less and telemetrycoil-less communication.

When LP 102, 104 senses an intrinsic event or delivers a paced event,the corresponding LP 102, 104 transmits an implant event message to theother LP 102, 104. For example, when an atrial LP 102 senses/paces anatrial event, the atrial LP 102 transmits an implant event messageincluding an event marker indicative of a nature of the event (e.g.,intrinsic/sensed atrial event, paced atrial event). When a ventricularLP 104 senses/paces a ventricular event, the ventricular LP 104transmits an implant event message including an event marker indicativeof a nature of the event (e.g., intrinsic/sensed ventricular event,paced ventricular event). In certain embodiments, LP 102, 104 transmitsan implant event message to the other LP 102, 104 preceding the actualpace pulse so that the remote LP can blank its sense inputs inanticipation of that remote pace pulse (to prevent inappropriatecrosstalk sensing).

The implant event messages may be formatted in various manners. As oneexample, each event message may include a leading trigger pulse (alsoreferred to as an LP wakeup notice or wakeup pulse) followed by an eventmarker. The notice trigger pulse is transmitted over a first channel(e.g., with a pulse duration of approximately 10 μs to approximately 1ms and/or within a fundamental frequency range of approximately 1 kHz toapproximately 100 kHz). The notice trigger pulse indicates that an eventmarker is about to be transmitted over a second channel (e.g., within ahigher frequency range). The event marker can then be transmitted overthe second channel.

The event markers may include data indicative of one or more events(e.g., a sensed intrinsic atrial activation for an atrial located LP, asensed intrinsic ventricular activation for a ventricular located LP).The event markers may include different markers for intrinsic and pacedevents. The event markers may also indicate start or end times fortimers (e.g., an AV interval, a blanking interval, etc.). Optionally,the implant event message may include a message segment that includesadditional/secondary information.

Optionally, the LP (or other IMD) that receives any implant to implant(i2i) communication from another LP (or other IMD) or from an externaldevice may transmit a receive acknowledgement indicating that thereceiving LP/IMD received the i2i communication, etc.

The event messages enable the LPs 102, 104 to deliver synchronizedtherapy and additional supportive features (e.g., measurements, etc.).To maintain synchronous therapy, each of the LPs 102 and 104 is madeaware (through the event messages) when an event occurs in the chambercontaining the other LP 102, 104. Some embodiments described hereinprovide efficient and reliable processes to maintain synchronizationbetween LPs 102 and 104 without maintaining continuous communicationbetween LPs 102 and 104. In accordance with certain embodiments herein,the transmitter(s) 118 and receiver(s) 120, 122 utilize low power eventmessages/signaling between multiple LPs 102 and 104. The low power eventmessages/signaling may be maintained between LPs 102 and 104synchronously or asynchronously.

For synchronous event signaling, LPs 102 and 104 maintainsynchronization and regularly communicate at a specific interval.Synchronous event signaling allows the transmitter and receivers in eachLP 102,104 to use limited (or minimal) power as each LP 102, 104 is onlypowered for a small fraction of the time in connection with transmissionand reception. For example, LP 102, 104 may transmit/receive (Tx/Rx)communications in time slots having duration of 10-20 μs, where theTx/Rx time slots occur periodically (e.g., every 10-20 ms). In theforegoing example, a receiver 120, 122 that is active/ON (also referredto as awake) for select receive time slots, that are spaced apartseveral milliseconds, may draw an amount of current that is severaltimes less (e.g., 1000× less) than a current draw of a receiver that is“always on” (always awake).

LPs 102 and 104 may lose synchronization, even in a synchronous eventsignaling scheme. As explained herein, features may be included in LPs102 and 104 to maintain device synchronization, and when synchronizationis lost, LPs 102 and 104 undergo operations to recover synchronization.Also, synchronous event messages/signaling may introduce a delay betweentransmissions which causes a reaction lag at the receiving LP 102, 104.Accordingly, features may be implemented to account for the reactionlag.

During asynchronous event signaling, LPs 102 and 104 do not maintaincommunication synchronization. During asynchronous event signaling, oneor more of receivers 120 and 122 of LPs 102 and 104 may be “always on”(always awake) to search for incoming transmissions. However,maintaining LP receivers 120, 122 in an “always on” (always awake) statepresents challenges as the received signal level often is low due tohigh channel attenuation caused by the patient's anatomy. Further,maintaining the receivers awake will deplete the battery 114 morequickly than may be desirable.

The asynchronous event signaling methods avoid risks associated withlosing synchronization between devices. However, the asynchronous eventsignaling methods utilize additional receiver current betweentransmissions. For purposes of illustration only, a non-limiting exampleis described hereafter. For example, the channel attenuation may beestimated to have a gain of 1/500 to 1/10000. A gain factor may be1/1000th. Transmit current is a design factor in addition to receivercurrent. As an example, the system may allocate one-half of the implantcommunication current budget to the transmitter (e.g., 0.5 μA for eachtransmitter). When LP 102, 104 maintains a transmitter in a continuouson-state and the electrode load is 500 ohms, a transmitted voltage maybe 0.250 mV. When an event signal is transmitted at 0.250 mV, the eventsignal is attenuated as it propagates and would appear at LP 102, 104receiver as an amplitude of approximately 0.25 μV. The receivers 120 and122 can utilize a synchronization threshold to help differentiateincoming communication signals from noise. As an example, thesynchronization threshold may be 0.5 μV (or more generally 0.25 μV to 5μV), which would cause LP 102, 104 receiver to reject an incomingcommunication signal that exhibits a receive voltage below 0.5 μV.Nevertheless, even with the use of the synchronization threshold, noisemay still be mistaken as being communication signals, and morespecifically, as being messages.

To overcome the foregoing receive power limit, a pulsed transmissionscheme may be utilized in which communication transmissions occurcorrelated with an event. By way of example, the pulsed transmissionscheme may be simplified such that each transmission constitutes asingle pulse of a select amplitude and width.

When LP transmitter 118 transmits event signals over a conductivecommunication channel that has an electrode load of 500 ohm using a 1 mspulse width at 2.5V at a rate of 60 bpm, LP transmitter 118 will draw4.4 μA for transmit current. When LP transmitter 118 transmits eventsignals at 2.5V using a 2 μs pulse width, transmitter 118 only draws 10nA to transmit event messages at a rate of 60 bpm. In order to sense anevent message (transmitted with the foregoing parameters), receivers 120and 122 may utilize 50 μA. In accordance with certain embodimentsherein, the pulse widths and other transmit/receive parameters may beadjusted to achieve a desired total (summed) current demand from bothtransmitter 118 and receivers 120 and 122. The transmitter currentdecreases nearly linearly with narrowing bandwidth (pulse width), whilea relation between receiver current and bandwidth is non-linear.

In accordance with certain embodiments herein, LPs 102 and 104 mayutilize multi-stage receivers that implement a staged receiver wakeupscheme in order to improve reliability yet remain power efficient. Eachof LPs 102 and 104 may include first and second receivers 120 and 122that operate with different first and second activation protocols anddifferent first and second receive channels. For example, first receiver120 may be assigned a first activation protocol that is “always on”(also referred to as always awake) and that listens over a first receivechannel that has a lower fundamental frequency range/pulse duration(e.g., 1 kHz to 100 kHz/10 μs to approximately 1 ms) as compared to thefundamental frequency range (e.g., greater than 100 kHz/less than 10 μsper pulse) assigned to the second receive channel. First receiver 120may maintain the first channel active (awake) for at least a portion ofa time when the second channel is inactive (asleep) to listen for eventmessages from a remote LP. The controller or processor determineswhether the incoming signal received over the first channel correspondsto an LP wakeup notice. The second receiver 122 may be assigned a secondactivation protocol that is a triggered protocol, in which the secondreceiver 122 becomes active (awake) in response to detection of triggerevents over the first receive channel (e.g., when the incoming signalcorresponds to the LP wakeup notice, activating the second channel atthe local LP).

The marker message may represent a signature indicative of an eventqualification to qualify a valid event marker pulse. The eventqualification messages distinguish a message from spurious noise andavoid mistaking other signals as event messages having implant markers.The event message may be repeated to allow the LP receiver 120 multiplechances to “catch” the event qualification. Additionally oralternatively, the Tx and Rx LP 102, 104 may implement a handshakingprotocol in which the Tx and Rx LP 102, 104 exchange additionalinformation, such as to allow a response to follow the marker. Theexchange of additional information may be limited or avoided in certaininstances as the exchange draws additional power when sending andreceiving the information. Optionally, the event message may beconfigured with additional content to provide a more robust eventmarker.

Transmitter 118 may be configured to transmit the event messages in amanner that does not inadvertently capture the heart in the chamberwhere LP 102, 104 is located, such as when the associated chamber is notin a refractory state. In addition, a LP 102, 104 that receives an eventmessage may enter an “event refractory” state (or event blanking state)following receipt of the event message. The event refractory/blankingstate may be set to extend for a determined period of time after receiptof an event message in order to avoid the receiving LP 102, 104 frominadvertently sensing another signal as an event message that mightotherwise cause retriggering. For example, the receiving LP 102, 104 maydetect a measurement pulse from another LP 102, 104 or programmer 109.

In accordance with certain embodiments herein, programmer 109 maycommunicate over a programmer-to-LP channel, with LP 102, 104 utilizingthe same communication scheme. The external programmer may listen to theevent message transmitted between LP 102, 104 and synchronize programmerto implant communication such that programmer 109 does not transmitcommunication signals 113 until after an implant to implant messagingsequence is completed.

In accordance with certain embodiments, LP 102, 104 may combine transmitoperations with therapy. The transmit event marker may be configured tohave similar characteristics in amplitude and pulse width to a pacingpulse and LP 102, 104 may use the energy in the event messages to helpcapture the heart. For example, a pacing pulse may normally be deliveredwith pacing parameters of 2.5V amplitude, 500 ohm impedance, 60 bpmpacing rate, 0.4 ms pulse width. The foregoing pacing parameterscorrespond to a current draw of about 1.9 μA. The same LP 102, 104 mayimplement an event message utilizing event signaling parameters foramplitude, pulse width, pulse rate, etc. that correspond to a currentdraw of approximately 0.5 μA for transmit.

LP 102, 104 may combine the event message transmissions with pacingpulses. For example, LP 102, 104 may use a 50 μs wakeup transmit pulsehaving an amplitude of 2.5V which would draw 250 nC (nano Coulombs) foran electrode load of 500 ohm. The pulses of the transmit event messagemay be followed by an event message encoded with a sequence of shortduration pulses (for example 16, 2 μs on/off bits) which would draw anadditional 80 nC. The event message pulse would then be followed by theremaining pulse width needed to reach an equivalent charge of a nominal0.4 ms pace pulse. In this case, the current necessary to transmit themarker is essentially free as it was used to achieve the necessary pacecapture anyhow. With this method, the savings in transmit current couldbe budgeted for the receiver or would allow for additional longevity.

When LP 102, 104 senses an intrinsic event, the transmitter sends aqualitatively similar event pulse sequence (but indicative of a sensedevent) without adding the pace pulse remainder. As LP 102, 104 longevitycalculations are designed based on the assumption that LP 102, 104 willdeliver pacing therapy 100% of the time, transmitting an intrinsic eventmarker to another LP 102, 104 will not impact the nominal calculated LPlongevity.

In some embodiments, LP 102, 104 may deliver pacing pulses at relativelylow amplitude. When low amplitude pacing pulses are used, the powerbudget for event messages may be modified to be a larger portion of theoverall device energy budget. As the pacing pulse amplitude is loweredcloser to amplitude of event messages, LP 102, 104 increases an extentto which LP 102, 104 uses the event messages as part of the pacingtherapy (also referred to as sharing “capture charge” and “transmitcharge”). As an example, if the nominal pacing voltage can be lowered to<1.25V, then a “supply halving” pacing charge circuit could reduce thebattery current draw by approximately 50%. A 1.25V pace pulse would save1.5 μA of pacing current budget. With lower pulse amplitudes, LP 102,104 may use larger pulse widths.

By combining event messages and low power pacing, LP 102, 104 mayrealize additional longevity. Today longevity standards provide that thelongevity to be specified based on a therapy that utilizes 2.5Vamplitude, 0.4 ms pulses at 100% pacing. Optionally, a new standard maybe established based on pacing pulses that deliver lower amplitudeand/or shorter pacing pulses.

In an embodiment, a communication capacitor is provided in LP 102, 104.The communication capacitor may be used to transmit event signals havinghigher voltage for the event message pulses to improve communication,such as when the LPs 102 and 104 experience difficulty sensing eventmessages. The high voltage event signaling may be used for implants withhigh signal attenuation or in the case of a retry for an ARQ (automaticrepeat request) handshaking scheme.

For example, when an LP 102, 104 does not receive an event messagewithin a select time out interval, LP 102, 104 may resend an eventmessage at a higher amplitude. As another example, LP 102, 104 mayperform an event signaling auto-level search wherein the LPs send eventmessages at progressively higher amplitude until receiving confirmationthat an event message was received (or receiving a subsequent eventmessage from another LP). For example, in DDD mode when the atrial orventricular LP 102, 104 does not see an event signal from LP 102, 104 inthe other chamber before its timeout interval it could automaticallyraise the amplitude of the event message, until the LPs 102 and 104become and remain in sync. Optionally, LP 102, 104 may implement asearch hysteresis algorithm similar to those used for rate and amplitudecapture to allow the lowest safe detectible amplitude to be determined.

The LPs 102 and 104 may be programmable such as to afford flexibility inadjusting the event marker pulse width. In some embodiments, differentreceiver circuits may be provided and selected for certain pulse widths,where multiple receivers may be provided on a common ASIC, therebyallowing the user to vary the parameters in an LP after implant.

In some embodiments, the individual LP 102 can comprise a hermetichousing 110 configured for placement on or attachment to the inside oroutside of a cardiac chamber and at least two leadless electrodes 108proximal to the housing 110 and configured for bidirectionalcommunication with at least one other device 106 within or outside thebody.

FIG. 2 depicts a single LP 102 and shows the LP's functional elementssubstantially enclosed in a hermetic housing 110. The LP 102 has atleast two electrodes 108 located within, on, or near the housing 110,for delivering pacing pulses to and sensing electrical activity from themuscle of the cardiac chamber, and for bidirectional communication withat least one other device within or outside the body. Hermeticfeedthroughs 130, 131 conduct electrode signals through the housing 110.The housing 110 contains a primary battery 114 to supply power forpacing, sensing, and communication. The housing 110 also containscircuits 132 for sensing cardiac activity from the electrodes 108,circuits 134 for receiving information from at least one other devicevia the electrodes 108, and a pulse generator 116 for generating pacingpulses for delivery via the electrodes 108 and also for transmittinginformation to at least one other device via the electrodes 108. Thehousing 110 can further contain circuits for monitoring device health,for example a battery current monitor 136 and a battery voltage monitor138, and can contain circuits for controlling operations in apredetermined manner.

Additionally or alternatively, one or more leadless electrodes 108 canbe configured to communicate bidirectionally among the multiple leadlesscardiac pacemakers and/or the implanted ICD 106 to coordinate pacingpulse delivery and optionally other therapeutic or diagnostic featuresusing messages that identify an event at an individual pacemakeroriginating the message and a pacemaker receiving the message react asdirected by the message depending on the origin of the message. An LP102, 104 that receives the event message reacts as directed by the eventmessage depending on the message origin or location. In some embodimentsor conditions, the two or more leadless electrodes 108 can be configuredto communicate bidirectionally among the one or more leadless cardiacpacemakers 102 and/or the ICD 106 and transmit data including designatedcodes for events detected or created by an individual pacemaker.Individual pacemakers can be configured to issue a unique codecorresponding to an event type and a location of the sending pacemaker.

In some embodiments, an individual LP 102, 104 can be configured todeliver a pacing pulse with an event message encoded therein, with acode assigned according to pacemaker location and configured to transmita message to one or more other leadless cardiac pacemakers via the eventmessage coded pacing pulse. The pacemaker or pacemakers receiving themessage are adapted to respond to the message in a predetermined mannerdepending on type and location of the event.

Moreover, information communicated on the incoming channel can alsoinclude an event message from another leadless cardiac pacemakersignifying that the other leadless cardiac pacemaker has sensed aheartbeat or has delivered a pacing pulse, and identifies the locationof the other pacemaker. For example, LP 104 may receive and relay anevent message from LP 102 to the programmer. Similarly, informationcommunicated on the outgoing channel can also include a message toanother leadless cardiac pacemaker or pacemakers, or to the ICD, thatthe sending leadless cardiac pacemaker has sensed a heartbeat or hasdelivered a pacing pulse at the location of the sending pacemaker.

Referring again to FIGS. 1 and 2, the cardiac pacing system 100 maycomprise an implantable cardioverter-defibrillator (ICD) 106 in additionto leadless cardiac pacemaker 102, 104 configured for implantation inelectrical contact with a cardiac chamber and for performing cardiacrhythm management functions in combination with the implantable ICD 106.The implantable ICD 106 and the one or more leadless cardiac pacemakers102, 104 configured for leadless intercommunication by informationconduction through body tissue and/or wireless transmission betweentransmitters and receivers in accordance with the discussed herein.

In a further embodiment, a cardiac pacing system 100 comprises at leastone leadless cardiac pacemaker 102, 104 configured for implantation inelectrical contact with a cardiac chamber and configured to performcardiac pacing functions in combination with the co-implantedimplantable cardioverter-defibrillator (ICD) 106. The leadless cardiacpacemaker or pacemakers 102 comprise at least two leadless electrodes108 configured for delivering cardiac pacing pulses, sensing evokedand/or natural cardiac electrical signals, and transmitting informationto the co-implanted ICD 106.

As shown in the illustrative embodiments, a leadless cardiac pacemaker102, 104 can comprise two or more leadless electrodes 108 configured fordelivering cardiac pacing pulses, sensing evoked and/or natural cardiacelectrical signals, and bidirectionally communicating with theco-implanted ICD 106.

LP 102, 104 can be configured for operation in a particular location anda particular functionality at manufacture and/or at programming by anexternal programmer. Bidirectional communication among the multipleleadless cardiac pacemakers can be arranged to communicate notificationof a sensed heartbeat or delivered pacing pulse event and encoding typeand location of the event to another implanted pacemaker or pacemakers.LP 102, 104 receiving the communication decode the information andrespond depending on location of the receiving pacemaker andpredetermined system functionality.

Also shown in FIG. 2, the primary battery 114 has positive terminal 140and negative terminal 142. Current from the positive terminal 140 ofprimary battery 114 flows through a shunt 144 to a regulator circuit 146to create a positive voltage supply 148 suitable for powering theremaining circuitry of the pacemaker 102. The shunt 144 enables thebattery current monitor 136 to provide the processor 112 with anindication of battery current drain and indirectly of device health. Theillustrative power supply can be a primary battery 114.

In various embodiments, LP 102, 104 can manage power consumption to drawlimited power from the battery, thereby reducing device volume. Eachcircuit in the system can be designed to avoid large peak currents. Forexample, cardiac pacing can be achieved by discharging a tank capacitor(not shown) across the pacing electrodes. Recharging of the tankcapacitor is typically controlled by a charge pump circuit. In aparticular embodiment, the charge pump circuit is throttled to rechargethe tank capacitor at constant power from the battery.

In some embodiments, the controller 112 in one leadless cardiacpacemaker 102 can access signals on the electrodes 108 and can examineoutput pulse duration from another pacemaker for usage as a signaturefor determining triggering information validity and, for a signaturearriving within predetermined limits, activating delivery of a pacingpulse following a predetermined delay of zero or more milliseconds. Thepredetermined delay can be preset at manufacture, programmed via anexternal programmer, or determined by adaptive monitoring to facilitaterecognition of the triggering signal and discriminating the triggeringsignal from noise. In some embodiments or in some conditions, thecontroller 112 can examine output pulse waveform from another leadlesscardiac pacemaker for usage as a signature for determining triggeringinformation validity and, for a signature arriving within predeterminedlimits, activating delivery of a pacing pulse following a predetermineddelay of zero or more milliseconds.

FIG. 3 shows an LP 102, 104. The LP can include a hermetic housing 202with electrodes 108 a and 108 b disposed thereon. As shown, electrode108 a can be separated from but surrounded partially by a fixationmechanism 205, and the electrode 108 b can be disposed on the housing202. The fixation mechanism 205 can be a fixation helix, a plurality ofhooks, barbs, or other attaching features configured to attach thepacemaker to tissue, such as heart tissue.

The housing can also include an electronics compartment 210 within thehousing that contains the electronic components necessary for operationof the pacemaker, including, for example, a pulse generator,communication electronics, a battery, and a processor for operation. Thehermetic housing 202 can be adapted to be implanted on or in a humanheart, and can be cylindrically shaped, rectangular, spherical, or anyother appropriate shapes, for example.

The housing can comprise a conductive, biocompatible, inert, andanodically safe material such as titanium, 316L stainless steel, orother similar materials. The housing can further comprise an insulatordisposed on the conductive material to separate electrodes 108 a and 108b. The insulator can be an insulative coating on a portion of thehousing between the electrodes, and can comprise materials such assilicone, polyurethane, parylene, or another biocompatible electricalinsulator commonly used for implantable medical devices. In theembodiment of FIG. 3, a single insulator 208 is disposed along theportion of the housing between electrodes 108 a and 108 b. In someembodiments, the housing itself can comprise an insulator instead of aconductor, such as an alumina ceramic or other similar materials, andthe electrodes can be disposed upon the housing.

As shown in FIG. 3, the pacemaker can further include a header assembly212 to isolate 108 a and 108 b. The header assembly 212 can be made fromPEEK, tecothane or another biocompatible plastic, and can contain aceramic to metal feedthrough, a glass to metal feedthrough, or otherappropriate feedthrough insulator as known in the art.

The electrodes 108 a and 108 b can comprise pace/sense electrodes, orreturn electrodes. A low-polarization coating can be applied to theelectrodes, such as sintered platinum, platinum-iridium, iridium,iridium-oxide, titanium-nitride, carbon, or other materials commonlyused to reduce polarization effects, for example. In FIG. 3, electrode108 a can be a pace/sense electrode and electrode 108 b can be a returnelectrode. The electrode 108 b can be a portion of the conductivehousing 202 that does not include an insulator 208.

Several techniques and structures can be used for attaching the housing202 to the interior or exterior wall of the heart. A helical fixationmechanism 205, can enable insertion of the device endocardially orepicardially through a guiding catheter. A torqueable catheter can beused to rotate the housing and force the fixation device into hearttissue, thus affixing the fixation device (and also the electrode 108 ain FIG. 3) into contact with stimulable tissue. Electrode 108 b canserve as an indifferent electrode for sensing and pacing. The fixationmechanism may be coated partially or in full for electrical insulation,and a steroid-eluting matrix may be included on or near the device tominimize fibrotic reaction, as is known in conventional pacingelectrode-leads.

Implant-to-Implant Event Messaging

LPs 102 and 104 can utilize implant-to-implant (i2i) communicationthrough event messages to coordinate operation with one another invarious manners. The terms i2i communication, i2i event messages, andi2i even markers are used interchangeably herein to refer to eventrelated messages and IMD/IMD operation related messages transmitted froman implanted device and directed to another implanted device (althoughexternal devices, e.g., a programmer, may also receive i2i eventmessages). In certain embodiments, LP 102 and LP 104 operate as twoindependent leadless pacers maintaining beat-to-beat dual-chamberfunctionality via a “Master/Slave” operational configuration. Fordescriptive purposes, the ventricular LP 104 shall be referred to as“vLP” and the atrial LP 102 shall be referred to as “aLP”. LP 102, 104that is designated as the master device (e.g. vLP) may implement all ormost dual-chamber diagnostic and therapy determination algorithms. Forpurposes of the following illustration, it is assumed that the vLP is a“master” device, while the aLP is a “slave” device. Alternatively, theaLP may be designated as the master device, while the vLP may bedesignated as the slave device. The master device orchestrates most orall decision-making and timing determinations (including, for example,rate-response changes).

In accordance with certain embodiments, methods are provided forcoordinating operation between first and second leadless pacemakers(LPs) configured to be implanted entirely within first and secondchambers of the heart. A method transmits an event marker throughconductive communication through electrodes located along a housing ofthe first LP, the event marker indicative of one of a local paced orsensed event. The method detects, over a sensing channel, the eventmarker at the second LP. The method identifies the event marker at thesecond LP based on a predetermined pattern configured to indicate thatan event of interest has occurred in a remote chamber. In response tothe identifying operation, the method initiates a related action in thesecond LP.

FIG. 4 is a timing diagram 400 demonstrating one example of an i2icommunication for a paced event. The i2i communication may betransmitted, for example, from LP 102 to LP 104. As shown in FIG. 4, inthis embodiment, an i2i transmission 402 is sent prior to delivery of apace pulse 404 by the transmitting LP (e.g., LP 102). This enables thereceiving LP (e.g., LP 104) to prepare for the remote delivery of thepace pulse. The i2i transmission 402 includes an envelope 406 that mayinclude one or more individual pulses. For example, in this embodiment,envelope 406 includes a low frequency pulse 408 followed by a highfrequency pulse train 410. Low frequency pulse 408 lasts for a periodT_(i2iLF), and high frequency pulse train 410 lasts for a periodT_(i2iHF). The end of low frequency pulse 408 and the beginning of highfrequency pulse train 410 are separated by a gap period, T_(i2iGap).

As shown in FIG. 4, the i2i transmission 402 lasts for a period Ti2iP,and pace pulse 404 lasts for a period Tpace. The end of i2i transmission402 and the beginning of pace pulse 404 are separated by a delay period,TdelayP. The delay period may be, for example, between approximately 0.0and 10.0 milliseconds (ms), particularly between approximately 0.1 msand 2.0 ms, and more particularly approximately 1.0 ms. The termapproximately, as used herein, means +/−10% of a specified value.

FIG. 5 is a timing diagram 500 demonstrating one example of an i2icommunication for a sensed event. The i2i communication may betransmitted, for example, from LP 102 to LP 104. As shown in FIG. 5, inthis embodiment, the transmitting LP (e.g., LP 102) detects the sensedevent when a sensed intrinsic activation 502 crosses a sense threshold504. A predetermined delay period, T_(delayS), after the detection, thetransmitting LP transmits an i2i transmission 506 that lasts apredetermined period T_(i2iS). The delay period may be, for example,between approximately 0.0 and 10.0 milliseconds (ms), particularlybetween approximately 0.1 ms and 2.0 ms, and more particularlyapproximately 1.0 ms.

As with i2i transmission 402, i2i transmission 506 may include anenvelope that may include one or more individual pulses. For example,similar to envelope 406, the envelope of i2i transmission 506 mayinclude a low frequency pulse followed by a high frequency pulse train.

Optionally, wherein the first LP is located in an atrium and the secondLP is located in a ventricle, the first LP produces an AS/AP eventmarker to indicate that an atrial sensed (AS) event or atrial paced (AP)event has occurred or will occur in the immediate future. For example,the AS and AP event markers may be transmitted following thecorresponding AS or AP event. Alternatively, the first LP may transmitthe AP event marker slightly prior to delivering an atrial pacing pulse.Alternatively, wherein the first LP is located in an atrium and thesecond LP is located in a ventricle, the second LP initiates anatrioventricular (AV) interval after receiving an AS or AP event markerfrom the first LP; and initiates a post atrial ventricular blanking(PAVB) interval after receiving an AP event marker from the first LP.

Optionally, the first and second LPs may operate in a “pure”master/slave relation, where the master LP delivers “command” markers inaddition to or in place of “event” markers. A command marker directs theslave LP to perform an action such as to deliver a pacing pulse and thelike. For example, when a slave LP is located in an atrium and a masterLP is located in a ventricle, in a pure master/slave relation, the slaveLP delivers an immediate pacing pulse to the atrium when receiving an APcommand marker from the master LP.

In accordance with some embodiments, communication and synchronizationbetween the aLP and vLP is implemented via conducted communication ofmarkers/commands in the event messages (per i2i communication protocol).As explained above, conducted communication represents event messagestransmitted from the sensing/pacing electrodes at frequencies outsidethe RF or Wi-Fi frequency range. Alternatively, the event messages maybe conveyed over communication channels operating in the RF or Wi-Fifrequency range. The figures and corresponding description belowillustrate non-limiting examples of markers that may be transmitted inevent messages. The figures and corresponding description below alsoinclude the description of the markers and examples of results thatoccur in the LP that receives the event message. Table 1 representsexemplary event markers sent from the aLP to the vLP, while Table 2represents exemplary event markers sent from the vLP to the aLP. In themaster/slave configuration, AS event markers are sent from the aLP eachtime that an atrial event is sensed outside of the post ventricularatrial blanking (PVAB) interval or some other alternatively-definedatrial blanking period. The AP event markers are sent from the aLP eachtime that the aLP delivers a pacing pulse in the atrium. The aLP mayrestrict transmission of AS markers, whereby the aLP transmits AS eventmarkers when atrial events are sensed both outside of the PVAB intervaland outside the post ventricular atrial refractory period (PVARP) orsome other alternatively-defined atrial refractory period.Alternatively, the aLP may not restrict transmission of AS event markersbased on the PVARP, but instead transmit the AS event marker every timean atrial event is sensed.

TABLE 1 “A2V” Markers/Commands (i.e., from aLP to vLP) MarkerDescription Result in vLP AS Notification of a sensed Initiate AVinterval event in atrium (if not (if not in PVAB in PVAB or PVARP) orPVARP) AP Notification of a paced Initiate PAVB event in atrium InitiateAV interval (if not in PVARP)

As shown in Table 1, when an aLP transmits an event message thatincludes an AS event marker (indicating that the aLP sensed an intrinsicatrial event), the vLP initiates an AV interval timer. If the aLPtransmits an AS event marker for all sensed events, then the vLP wouldpreferably first determine that a PVAB or PVARP interval is not activebefore initiating an AV interval timer. If however the aLP transmits anAS event marker only when an intrinsic signal is sensed outside of aPVAB or PVARP interval, then the vLP could initiate the AV intervaltimer upon receiving an AS event marker without first checking the PVABor PVARP status. When the aLP transmits an AP event marker (indicatingthat the aLP delivered or is about to deliver a pace pulse to theatrium), the vLP initiates a PVAB timer and an AV interval time,provided that a PVARP interval is not active. The vLP may also blank itssense amplifiers to prevent possible crosstalk sensing of the remotepace pulse delivered by the aLP.

TABLE 2 “V2A” Markers/Commands (i.e., from vLP to aLP) MarkerDescription Result in aLP VS Notification of a sensed Initiate PVARPevent in ventricle VP Notification of a paced Initiate PVAB event inventricle Initiate PVARP AP Command to deliver immediate Deliverimmediate pace pace pulse in atrium pulse to atrium

As shown in Table 2, when the vLP senses a ventricular event, the vLPtransmits an event message including a VS event marker, in response towhich the aLP may initiate a PVARP interval timer. When the vLP deliversor is about to deliver a pace pulse in the ventricle, the vLP transmitsVP event marker. When the aLP receives the VP event marker, the aLPinitiates the PVAB interval timer and also the PVARP interval timer. TheaLP may also blank its sense amplifiers to prevent possible crosstalksensing of the remote pace pulse delivered by the vLP. The vLP may alsotransmit an event message containing an AP command marker to command theaLP to deliver an immediate pacing pulse in the atrium upon receipt ofthe command without delay.

The foregoing event markers are examples of a subset of markers that maybe used to enable the aLP and vLP to maintain full dual chamberfunctionality. In one embodiment, the vLP may perform all dual-chamberalgorithms, while the aLP may perform atrial-based hardware-relatedfunctions, such as PVAB, implemented locally within the aLP. In thisembodiment, the aLP is effectively treated as a remote ‘wireless’ atrialpace/sense electrode. In another embodiment, the vLP may perform mostbut not all dual-chamber algorithms, while the aLP may perform a subsetof diagnostic and therapeutic algorithms. In an alternative embodiment,vLP and aLP may equally perform diagnostic and therapeutic algorithms.In certain embodiments, decision responsibilities may be partitionedseparately to one of the aLP or vLP. In other embodiments, decisionresponsibilities may involve joint inputs and responsibilities.

In an embodiment, ventricular-based pace and sense functionalities arenot dependent on any i2i communication, in order to provide safertherapy. For example, in the event that LP to LP (i2i) communication islost (prolonged or transient), the system 100 may automatically revertto safe ventricular-based pace/sense functionalities as the vLP deviceis running all of the necessary algorithms to independently achievethese functionalities. For example, the vLP may revert to a VVI mode asthe vLP does not depend on i2i communication to perform ventricularpace/sense activities. Once i2i communication is restored, the system100 can automatically resume dual-chamber functionalities.

Mitigating False Messages

As noted above, implantable medical devices and systems often rely onproper communications to operate correctly. For example, in a dualchamber pacemaker system, such as the one described above with referenceto FIGS. 1-5, i2i communications are critical for proper synchronizationof the system. However, noise may cause one or more devices of such asystem to falsely detect a message and inappropriately respond thereto.For a more specific example, noise may cause a ventricular LP to falselydetect a message from an atrial LP, which then could trigger theventricular LP to pace at an inappropriate high-rate, and moregenerally, at one or more inappropriate times. As also noted above, suchmessages can include redundant data for error detection and correction.However, due to the desire to keep the power consumption low, themessaging and/or error correction and detection scheme may be simple andfalse messages may still get through.

Certain embodiments of the present technology, which will be initiallydescribed with reference to the high level flow diagram of FIG. 6A, canbe used to reduce how often an IMD, such as a ventricular LP (e.g., 104)or an atrial LP (e.g., 102), accept false messages. When a message isaccepted by an IMD, the IMD may to trigger a timer, trigger an eventand/or otherwise be responsive to the message to control or provide aninstruction to the IMD that received the message. By contrast, when amessage is rejected, this means that the message is prevented (e.g.,blocked) from being used to trigger a timer, trigger an event and/orotherwise being used to control or provide an instruction to the IMDthat received the message.

Referring to FIG. 6A, step 602 involves receiving a message, wherein themessage that is received at step 602 may not actually be a true message,but rather, may be a false message. The term “message”, as used herein,can refer to an actual sent message that is received and is capable ofbeing decoded by an IMD, an actual sent message that is received but istoo noisy to be decoded by the IMD, an actual sent message that isreceived but due to noise it is decoded mistakenly for a differentmessage, noise that is received and is initially mistaken for being anactual message but cannot be decoded by the IMD because it issufficiently different than an actual message, as well as noise that isreceived and is mistaken for being an actual message and is decoded bythe IMD because it is sufficiently similar than an actual message. Theterm “false message”, as used herein, refers to noise that is receivedand decoded by the IMD and is mistaken for being an actual messagebecause it is sufficiently similar to an actual message. The term “falsemessage”, as used herein, can also refer to an actual sent message thatis received but due to noise it is decoded mistakenly for a differentmessage. The term “true message”, as used herein, refers to an actualsent message that is received by an IMD and is correctly decoded by theIMD. An actual sent message may have been sent by another IMD, oralternatively, by a non-implanted device.

Still referring to FIG. 6A, step 604 involves performing error detectionand correction on the message received at step 602. Error detectiongenerally refers to the detection of errors caused by noise or otherimpairments during transmission from a transmitter of one device to areceiver of another device. Error correction generally refers to thedetection of errors and reconstruction of the original, error-free data,if possible.

Typically, to enable error detection and correction to be performed,some redundancy (i.e., some extra data) is added to a message, whichenables a receiver to check consistency of the received message, and torecover data determined to be corrupted. Error detection is oftenrealized using a suitable hash function (or checksum algorithm) thatadds a fixed-length tag to a message, which enables receivers to verifythe delivered message by recomputing the tag and comparing it with theone provided. For example, a repetition code can be used, where arepetition code is a coding scheme that repeats the bits across achannel to attempt to achieve error-free communication. Such arepetition code is often inefficient, and can be susceptible to problemsif the error occurs in exactly the same place for each group. However,an advantage of repetition codes is that they are extremely simple, andthus, are typically power efficient compared to more complex schemes.Instead of, or in addition to a repetition code, parity bits can beused, wherein a parity bit is a bit that is added to a group of sourcebits to ensure that a number of set bits (e.g., bits with value 1) inthe outcome is even or odd. Alternatively, or additionally, checksumsand/or cyclic redundancy checks can be utilized. A checksum of a messageis a modular arithmetic sum of message code words of a fixed word length(e.g., byte values). The sum may be negated by means of aones'-complement operation prior to transmission to detect errorsresulting in all-zero messages. Checksum schemes can include paritybits, check digits, and longitudinal redundancy checks. A cyclicredundancy check (CRC) is a non-secure hash function designed to detectaccidental changes to digital data.

Where an error is detected in a received message, such an error mayoften be corrected. Such error correction may involve the use of anautomatic repeat request, an error-correcting code or a hybrid scheme,but is not limited thereto. Automatic repeat request (ARQ) is an errorcontrol technique for data transmission that makes use oferror-detection codes, acknowledgment and/or negative acknowledgmentmessages, and timeouts to achieve reliable data transmission. Anacknowledgment is a message sent by the receiver to indicate that it hascorrectly received a data frame. Usually, when a transmitter does notreceive the acknowledgment before the timeout occurs (e.g., within areasonable amount of time after sending the data frame), it retransmitsthe frame until it is either correctly received or the error persistsbeyond a predetermined number of retransmissions. An error-correctingcode (ECC) or forward error correction (FEC) code is a process of addingredundant data, or parity data, to a message, such that it can berecovered by a receiver even when a number of errors (up to thecapability of the code being used) were introduced, either during theprocess of transmission, or on storage. Since the receiver does not haveto ask the sender for retransmission of the data, a backchannel is notrequired in forward error correction, and it is therefore suitable forsimplex communication such as broadcasting. Hybrid ARQ is a combinationof ARQ and forward error correction.

The above description has been included to provide a high level ofpossible error correction and detection schemes, and is not intended tobe limiting and/or all encompassing, as the embodiments of the presenttechnology can be used with almost any already developed or futuredeveloped error correction and detection schemes.

Still referring to FIG. 6A, at decision step 606, there is adetermination of whether the received message was uncorrectable, i.e.,was not corrected at step 604. If the answer to the determination atstep 606 is YES, then the message is rejected, as indicated at step 624.As noted above, if the message is rejected, this means that the messageis prevented (e.g., blocked) from being used to trigger a timer, triggeran event and/or otherwise being used to control or provide aninstruction to the IMD that received the message. If the message was notuncorrectable, e.g., because it was received cleanly, or was correctedat step 604, then the answer to the determination at step 606 is NO andflow goes to step 608.

Step 608 involves measuring a message interval indicative of a length oftime between when the message was received and when a preceding messagewas received. An example of such a message interval is shown in FIG. 7,which is a timing diagram illustrating an exemplary message interval712, an exemplary message window 716 and an exemplary window positioninginterval 714. Referring briefly to FIG. 7, the message that is receivedat step 602 is represented by the i2i transmission 706 _(N), and thepreceding message (that was received during a previous instance of step602) is represented by the i2i transmission 706 _(N-1). The messageinterval 712 that is measured at step 608 is the length of time betweenwhen the message (represented by the i2i transmission 706 _(N)) wasreceived and when the preceding message (represented by the i2itransmission 706 _(N-1)) was received. As can be appreciated from FIG.7, the window positioning interval 714 is indicative of a length of timebetween when the preceding message (represented by the i2i transmission706 _(N-1)) was received and a center of a message window 716, whereinthe message window 716 specifies a window or range of time during whichit is expected that a message may be received. The width of the messagewindow 716 may be fixed (e.g., 200 ms, but not limited thereto), or aswill be described below, may be variable.

Referring again to FIG. 6A, step 610 involves determining, based on themeasured message interval, whether the message was received within themessage window. At decision step 612, there is a determination, based onthe results of step 610, of whether the message was received within themessage window. Referring briefly to FIG. 7, in this example, themessage 706 _(N) is shown as being received within the message window716. Accordingly, the answer to the determination at step 612 would beYES. However, it can be appreciated from FIG. 7 that it is also possiblethat the message 706 _(N) could have been received prior to or after themessage window 716, in which case the answer to the determination atstep 612 would be NO, and the message would be rejected at indicatedstep 624. More generally, certain embodiments of the present technologyinvolve determining that a message should be rejected if the message wasnot received within a message window, and determining that the messageshould not be rejected if the message was received within the messagewindow. This is because there is a high probability that a receivedmessage is a false message if the message is received outside themessage window, and more specifically, outside of when the message isexpected.

Referring again to FIG. 6A, if the answer to the determination at step612 is YES, then flow goes to step 614, which involves adjusting atemporal position of the message window based on the measured messageinterval. In accordance with certain embodiments, step 614 can involvecomparing the measured message interval (e.g., 712 in FIG. 7) to awindow positioning interval (e.g., 714 in FIG. 7) indicative of a lengthof time between when the preceding message was received and a center ofthe message window. Additionally, step 614 can involve increasing thewindow positioning interval if the measured message interval was greaterthan the window positioning interval, and decreasing the windowpositioning interval if the measured message interval was less than thewindow positioning interval. If the measured message interval is thesame as the window positioning interval, or the same within somespecified tolerance (e.g., ±10 ms), then there can be no change to thewindow positioning interval.

As noted above, a message may be sent by one IMD (e.g., an atrial LP)and received by another IMD (e.g., a ventricular LP), wherein themessage is indicative of when the atrial LP sensed an intrinsic atrialdepolarization or delivered an atrial pacing pulse. In this, and similarembodiments, the timing of when messages are sent and received will bebased on the heart rate of the patient. Adjusting the temporal positionof the message window, in accordance with an embodiment describedherein, enables the temporal position of the message window to beappropriately adjusted to track increases and decreases in sinus orpaced heart rate. In other words, the message window can be adjustedincrementally on each beat to allow for an increasing and decreasingsinus or paced heart rate.

Referring again to FIG. 7, the message window 716 can be thought of asincluding a first half that extends between a beginning of the messagewindow and a center of the message window, and a second half thatextends between the center of the message window and an end of themessage window. In certain embodiments, in order to adjust the temporalposition of the message window based on the measured message interval,the temporal position of the message window is decreased if the messagewas received in the first half of the message window, and the temporalposition of the message window is increased if the message was receivedin the second half of the message window.

In accordance with certain embodiments, whenever the window positioninginterval is increased it is increased by a fixed increment amount (e.g.,50 ms), and whenever the window positioning interval is decreased, it isdecreased by a fixed decrement amount, which may or may not be the sameas the fixed increment amount, depending upon implementation. Inaccordance with other embodiments, whenever the window positioninginterval is increased it is increased by a fixed increment percentage(e.g., 5% or 10%), and whenever the window positioning interval isdecreased, it is decreased by a fixed decrement percentage, which may ormay not be the same as the fixed increment percentage, depending uponimplementation. In further embodiments, when the window positioninginterval is to be increased (due to the measured message interval beinggreater than the expected message interval), the window positioninginterval is set to be equal to the measured message interval, and whenthe window positioning interval is to be decreased (due to the measuredmessage interval being less than the expected message interval), thewindow positioning interval is set to be equal to the measured messageinterval. In still other embodiments, when the window positioninginterval is to be increased (due to the measured message interval beinggreater than the expected message interval), the window positioninginterval is set to be equal to the measured message interval if themeasured message interval is within a specified amount (e.g., 50 ms) ora specified percentage (e.g., 10%) of the expected message interval,otherwise the window positioning interval is increased by a fixedincrement amount (e.g., 50 ms) or a fixed increment percentage (e.g.,10%). Similarly when the window positioning interval is to be decreased(due to the measured message interval being less than the expectedmessage interval), the window positioning interval is set to be equal tothe measured message interval if the measured message interval is withina specified amount (e.g., 50 ms) or a specified percentage (e.g., 10%)of the expected message interval, otherwise the window positioninginterval is decreased by a fixed decrement amount (e.g., 50 ms) or afixed decrement percentage (e.g., 10%). The fixed increment amount orpercentage can be the same or different than the fixed decrement amountor percentage, depending upon implementation. In still otherembodiments, measured message intervals can be filtered or averaged overtime and the temporal position of the message window can be basedthereon, e.g., set equal to an average of a plurality of most recentlymeasured message intervals. Other variations are also possible andwithin embodiments of the present technology.

In accordance with certain embodiments, the window positioning interval(e.g., 714 in FIG. 7) cannot be adjusted to go outside a specified rangethat defines a minimum window positioning interval and a maximum windowpositioning interval. This has the effect of keeping the message windowwithin an expected temporal range.

Where a method described with reference to FIGS. 6 and 7 is being usedwith a dual chamber pacemaker system, such as the one introduced abovewith reference to FIGS. 1-5, it is possible that the atrial LP detects apremature atrial contraction (PAC) and sends a message indicativethereof to the ventricular LP that would be outside the message window.In accordance with certain embodiments of the present technology, themethod is configured such that at least one message sent by an atrialLP, in response to a PAC being detected, is not rejected by aventricular LP, but causes one or more subsequent messages received bythe ventricular LP outside their respective message windows to berejected. For example, in certain embodiments, determining whether toreject a message can involve determining that the message should berejected if the message was not received within the message window and Mpreceding message(s) were also not received within their respectivemessage window(s) (wherein M is a predetermined integer that is ≥1).Such a method can also include determining that the message should notbe rejected if the message was received within the message window, anddetermining that the message should not be rejected if the message wasnot received within the message window but at least one of the Mpreceding message(s) was received within its respective message window.If M is set to be equal to 1, then a message corresponding to one PACwould be let through, or more generally, not rejected due to beingoutside its message window. If M is set to be equal to 2, then twoconsecutive messages corresponding to two consecutive PACs would be letthrough, or more generally, not rejected due to being outside theirrespective message windows.

As noted above, the message window (e.g., 716 in FIG. 7) can have afixed width. Alternatively, a temporal width of the message window canbe adjusted based on a measured message interval. For example, incertain embodiments the message window can be a specified percentage(e.g., 10%) of the most recently measured message window, or a specifiedpercentage (e.g., 10%) of a running average of a plurality of the mostrecently measured message window.

In accordance with certain embodiments, if a message is notuncorrectable (as determined at step 606), and the message is receivedwithin the message window (as determined at step 612), then the messagewill be accepted. In other words, referring to FIG. 6A, in certainembodiments if the answer to the determination at step 612 is YES, thenflow can jump from step 614 to step 622 and the message is accepted(e.g., as shown in FIG. 6C). In other embodiments, the quality of thereceived message and/or the channel over which the message was receivedis/are also taken into account, to better prevent false messages frombeing accepted.

More specifically, referring to FIG. 6A, step 616 involves determiningone or more quality measure(s) indicative of a quality of the messageand/or a quality of a channel over which the message was received. Then,step 618 involves comparing the quality measure(s) to one or morethresholds, in order to determine, at step 620, whether the qualitymeasure(s) are within acceptable range(s). More generally, certainembodiments involve determining whether to reject the message based onone or more quality measure(s). If the answer to the determination atstep 620 is NO, then the message is rejected, as indicated at step 624.If the answer to the determination at step 620 is YES, then the messageis not rejected, and more specifically, is accepted at step 622.Beneficially, determining whether or not to reject a received messagebased on message quality and/or the quality of a channel over which themessage is received reduces the probability that noise will be mistakenfor being a true message, and also reduce the probability of acceptingan actual sent message that is received but due to noise it is decodedmistakenly for a different message. More generally, determining whetheror not to reject a received message based on message quality and/or thequality of a channel over which the message is received reduces theprobability that false messages will be accepted. Additional details ofhow to perform steps 616, 618 and 620 will be described below.

In FIG. 6A, steps 608 through 614 are shown as being performed prior tosteps 616 through 620. In alternative embodiments, steps 616 through 620are performed prior to steps 608 through 614 (e.g., as shown in FIG.6B). More generally, determining whether to reject a received messagebased on whether it is received within its message window can beperformed before, or after, determining whether to reject the receivedmessage based on its quality and/or the quality of the channel overwhich the message was received. Other variations are also possible, andwithin the embodiments described herein.

In accordance with certain embodiments, step 616 involves determining aquality measure indicative of a quality of the message based on resultsof the error detection and correction performed at step 604. In certainsuch embodiments, the results of the error detection and correctionperformed at step 604 specify one of at least two different levels ofmessage quality, which are used to determine such a quality measure.This can involve mapping the results of the error detection andcorrection to one of at least two different numbers (e.g., to one of thenumbers 2, 1 or 0), adjusting an average message quality based on thenumber, and comparing the average message quality to one or morethresholds. For example, if the message received at step 602 was cleanlyreceived, such that no errors were detected and thus it did not requireany correction, then the message may be mapped to the number 2; if themessage included an error but was correctable, then the message may bemapped to the number 1; and if the message included an error and was notcorrectable, then the message may be mapped to the number 0. In otherwords, in this embodiment, a higher value represents better messagequality, and a lower value represents worse message quality. Alternativenumbers can be used for the mapping, besides those provided above. Foranother example, if the message received at step 602 was cleanlyreceived, such that no errors were detected and thus it did not requireany correction, then the message may be mapped to the number 5; if themessage included an error but was correctable, then the message may bemapped to the number 2; and if the message included an error and was notcorrectable, then the message may be mapped to the number 0. In certainembodiments, if multiple bits of a message can be corrected, the valueto which the message is mapped can be inversely related to the number ofbits that required correction, or can be mapped to the negative of thenumber of bits that required correction. Other variations are alsopossible and within the scope of embodiments of the present technology.

The average message quality can then be adjusted based on the number towhich the message was mapped, e.g., using the equationQ=(1−1/b)*Q+N*(1/b), where Q is the average message quality, N is thenumber to which the message was mapped, and b is a time constantparameter that controls a rate of change. This equation provides for anexponentially weighted average. Other equations, such as, but notlimited to, a simple moving average (e.g., the sum of the messagequality of the last M samples, divided by M) can alternatively be used.There are alternative and/or additional ways in which the messagequality, or an average thereof, can be determined and used to determinewhether a message should be rejected. For example, an amplitude and/orsignal strength of a message can be compared to an expected amplitudeand/or signal strength range, and the message can be determined to be afalse message that should be rejected if the amplitude and/or signalstrength is/are outside the expected amplitude and/or signal strengthrange.

An average message quality or other measure of message quality can becompared to one or more thresholds to determine whether a receivedmessage should be rejected. For example, if the measure is above aquality threshold, there may be a determination that the message shouldnot be rejected, and if the measure is below the quality threshold, thenthere may be a determination that the message should be rejected. Toprovide hysteresis, more than one threshold may be used, e.g., there canbe an upper threshold and a lower threshold. If the measure is above theupper threshold, then there may be a determination that the messageshould not be rejected, and if the measure is below the lower threshold,then there may be a determination that the message should be rejected.If the measure is between the two thresholds, then whatever wasdetermined for the preceding message can be used for the currentmessage. For example, if the measure is between the upper and lowerthresholds, and there was a determination that the preceding messageshould not be rejected, then there can also be a determination that thecurrent message should not be rejected. On the other hand, if themeasure is between the upper and lower thresholds, and there was adetermination that the preceding message should be rejected, then therecan also be a determination that the current message be rejected. Othervariations are also possible.

Additionally, or alternatively, a quality of the channel over which themessage was received can also be used to determine whether to reject thereceived message. For example, noise in the channel over which themessage was received can be monitored, and the higher the noise thelower the quality of the channel, and the lower the noise the higher thequality of the channel. For another example, the amplitude of a messagesignal can be monitored, and the lower the amplitude the lower thequality of the channel, and the higher the amplitude the higher thequality of the channel. For still another example, a wakeup pulse (e.g.,408) of a message can be monitored, and the more it deviates from aspecified morphology (e.g., too narrow or too wide), the lower thequality of the channel, and the closer it is to its specified morphologythe higher the quality of the channel. The use of alternative and/oradditional techniques for determining the quality of the channel overwhich a message was or can be received can also be used to determinewhether to reject or accept a received message. In a similar manner aswas discussed above, measures of channel quality can be averaged andcompared to one or more thresholds to determine whether a receivedmessage should be rejected.

Where various different types of measures are determined at step 616,the various measures may be combined and compared to one or morethresholds. The various measures can be equally weighted, or differentlyweighted, when combined. Alternatively, each different type of measurescan be compared to one or more respective thresholds, and the resultsthereof can be used to determine whether the received message should berejected. Depending upon implementation, all results can be equallyweighted, or different results can be differently weighted. Inaccordance with an embodiment, where each of a plurality of differentmeasures of quality are each compared to their own respectivethreshold(s), then there is a determination that a message should berejected if at least one of the measures does not satisfy its respectivethreshold(s). In accordance with another embodiment, where each of aplurality of different measures of quality are each compared to theirown respective threshold(s), then there is a determination that amessage should be rejected only all of the measures do not satisfy theirrespective threshold(s). In still another embodiment, there is adetermination that a message should be rejected only at least a majorityof the measures do not satisfy their respective threshold(s). Othervariations are also possible and within the scope of the embodimentsdescribed herein.

In FIG. 6A (and FIGS. 6B, 6C and 6D discussed below) if there is adetermination that a message is uncorrectable, i.e., if the answer tothe determination at step 606 is YES, then flow is shown as goingdirectly to step 624 where the message is rejected. However, even insuch a case, the mapping of the results of the error detection andcorrection to one of at least two different numbers (e.g., to one of thenumbers 2, 1 or 0), and the adjusting an average message quality basedon the number, e.g., using the equation Q=(1−1/b)*Q+N*(1/b), or someother equation, can still be performed so that Q is appropriatelyupdated to provide a weighted average of message quality over time.

In FIG. 6A (and FIGS. 6B and 6C discussed below), step 614 (whichinvolves adjusting the temporal position of the message window based onthe measured message interval) was shown as occurring only if themessage was received within the message window, i.e., if the answer tothe determination at step 612 is YES. In certain embodiments, even ifthe answer to the determination at step 612 is NO, step 614 is stillperformed before the message is rejected at step 624. Such embodimentscan be achieved by performing step 614 prior to step 612, e.g., betweensteps 610 and 612, or between steps 608 and 610. In other words, thetemporal position of the window can be adjusted based on the measuredmessage interval regardless of whether a message was received within themessage window. This should beneficially prevent situations fromoccurring where true messages begin to fall outside the message window(e.g., due to sudden changes in an atrial activity) that would make itdifficult for the temporal adjustments to the message window to catchup.

Where step 616 involves determining the quality of a channel over whichmessages are or can be received, step 616 can be triggered in responseto a message being received at step 602. Alternatively, step 616 can beperformed continually, periodically, or in response to some othertriggering event(s), and the most recent results of step 616 can be usedwhenever a message is received and there is the need to determinewhether to accept or reject the received message.

In alternative embodiments, the order of the steps shown in anddescribed with reference to FIG. 6A are rearranged. In other words,embodiments of the present technology are not limited to the order inwhich the steps described with reference to FIG. 6A are performed. Forexample, in accordance with certain embodiments, step 616, 618 and 620are performed prior steps 608, 610, 612 and 614, as shown in FIG. 6B.Other variations are also possible and within the scope of theembodiments described herein. For an example, the order of steps 614 and622 shown in FIG. 6B can be swapped. Further, as already noted above,step 614 can be performed prior to step 612, e.g., between steps 610 and612, or between steps 608 and 610.

In the embodiments summarized with reference to FIGS. 6A and 6B,determinations of whether to reject a received message may be based onboth the timing of when a message was received relative to one or morepreceding messages, as well one or more measures of quality, which asexplained above, can relate to message quality and/or quality of thechannel over which a message was received.

In accordance with other embodiments, determinations of whether toreject a received message are based on the timing of when a message wasreceived relative to one or more preceding messages, without being basedon any measures message quality and/or quality of the channel over whicha message was received. An example of such an embodiment is shown, forexample, in FIG. 6C. A comparison between FIG. 6C and FIGS. 6A and 6Bshows that FIG. 6C does not include steps 616, 618 and 620.

In accordance with further embodiments, determinations of whether toreject a received message are based on measures of message qualityand/or quality of the channel over which a message was received, withoutbeing based on the timing of when the message was received relative toone or more preceding messages. An example of such an embodiment isshown, for example, in FIG. 6D. A comparison between FIG. 6D and FIGS.6A and 6B shows that FIG. 6D does not include steps 608, 610, 612 and614.

A reason for using one of the embodiments of FIG. 6C or 6D instead ofone of the embodiments of FIG. 6A or 6B is that they would likely bemore simple and easier to implement in an IMD, especially in a rathersmall IMD such as an LP. A reason for using one of the embodiments ofFIG. 6A or 6B instead of one of the embodiments of FIG. 6C or 6D is thatthe embodiments of FIG. 6A or 6B should reject more false messages thanthe embodiments of FIG. 6C or 6D, since the embodiments of FIGS. 6A and6B scrutinize received messages to a greater extent than the embodimentsof FIGS. 6C and 6D. A reason for using the embodiment of FIG. 6D insteadof the embodiment of FIG. 6C is that the embodiment of FIG. 6C wouldlikely be more simple and easier to implement in an IMD, especially arather small IMD such as an LP.

FIG. 8 shows a block diagram of one embodiment of an LP 801 that isimplanted into the patient as part of the implantable cardiac system inaccordance with certain embodiments herein. LP 801 may be implemented asa full-function biventricular pacemaker, equipped with both atrial andventricular sensing and pacing circuitry for four chamber sensing andstimulation therapy (including both pacing and shock treatment).Optionally, LP 801 may provide full-function cardiac resynchronizationtherapy. Alternatively, LP 801 may be implemented with a reduced set offunctions and components. For instance, the IMD may be implementedwithout ventricular sensing and pacing.

LP 801 has a housing 800 to hold the electronic/computing components.Housing 800 (which is often referred to as the “can”, “case”,“encasing”, or “case electrode”) may be programmably selected to act asthe return electrode for certain stimulus modes. Housing 800 may furtherinclude a connector (not shown) with a plurality of terminals 802, 804,806, 808, and 810. The terminals may be connected to electrodes that arelocated in various locations on housing 800 or elsewhere within andabout the heart. LP 801 includes a programmable microcontroller 820 thatcontrols various operations of LP 801, including cardiac monitoring andstimulation therapy. Microcontroller 820 includes a microprocessor (orequivalent control circuitry), RAM and/or ROM memory, logic and timingcircuitry, state machine circuitry, and I/O circuitry.

LP 801 further includes a first pulse generator 822 that generatesstimulation pulses for delivery by one or more electrodes coupledthereto. Pulse generator 822 is controlled by microcontroller 820 viacontrol signal 824. Pulse generator 822 may be coupled to the selectelectrode(s) via an electrode configuration switch 826, which includesmultiple switches for connecting the desired electrodes to theappropriate I/O circuits, thereby facilitating electrodeprogrammability. Switch 826 is controlled by a control signal 828 frommicrocontroller 820.

In the embodiment of FIG. 8, a single pulse generator 822 isillustrated. Optionally, the IMD may include multiple pulse generators,similar to pulse generator 822, where each pulse generator is coupled toone or more electrodes and controlled by microcontroller 820 to deliverselect stimulus pulse(s) to the corresponding one or more electrodes.

Microcontroller 820 is illustrated as including timing control circuitry832 to control the timing of the stimulation pulses (e.g., pacing rate,atrio-ventricular (AV) delay, atrial interconduction (A-A) delay, orventricular interconduction (V-V) delay, etc.). Timing control circuitry832 may also be used for the timing of refractory periods, blankingintervals, noise detection windows, evoked response windows, alertintervals, marker channel timing, and so on. Microcontroller 820 alsohas an arrhythmia detector 834 for detecting arrhythmia conditions and amorphology detector 836. Although not shown, the microcontroller 820 mayfurther include other dedicated circuitry and/or firmware/softwarecomponents that assist in monitoring various conditions of the patient'sheart and managing pacing therapies.

LP 801 is further equipped with a communication modem(modulator/demodulator) 840 to enable wireless communication with theremote slave pacing unit. Modem 840 may include one or more transmittersand two or more receivers as discussed herein in connection with FIG.1B. In one implementation, modem 840 may use low or high frequencymodulation. As one example, modem 840 may transmit i2i messages andother signals through conductive communication between a pair ofelectrodes. Modem 840 may be implemented in hardware as part ofmicrocontroller 820, or as software/firmware instructions programmedinto and executed by microcontroller 820. Alternatively, modem 840 mayreside separately from the microcontroller as a standalone component.

LP 801 includes a sensing circuit 844 selectively coupled to one or moreelectrodes, that perform sensing operations, through switch 826 todetect the presence of cardiac activity in the right chambers of theheart. Sensing circuit 844 may include dedicated sense amplifiers,multiplexed amplifiers, or shared amplifiers. It may further employ oneor more low power, precision amplifiers with programmable gain and/orautomatic gain control, bandpass filtering, and threshold detectioncircuit to selectively sense the cardiac signal of interest. Theautomatic gain control enables the unit to sense low amplitude signalcharacteristics of atrial fibrillation. Switch 826 determines thesensing polarity of the cardiac signal by selectively closing theappropriate switches. In this way, the clinician may program the sensingpolarity independent of the stimulation polarity.

The output of sensing circuit 844 is connected to microcontroller 820which, in turn, triggers or inhibits the pulse generator 822 in responseto the presence or absence of cardiac activity. Sensing circuit 844receives a control signal 846 from microcontroller 820 for purposes ofcontrolling the gain, threshold, polarization charge removal circuitry(not shown), and the timing of any blocking circuitry (not shown)coupled to the inputs of the sensing circuitry.

In the embodiment of FIG. 8, a single sensing circuit 844 isillustrated. Optionally, the IMD may include multiple sensing circuits,similar to sensing circuit 844, where each sensing circuit is coupled toone or more electrodes and controlled by microcontroller 820 to senseelectrical activity detected at the corresponding one or moreelectrodes. Sensing circuit 844 may operate in a unipolar sensingconfiguration or in a bipolar sensing configuration.

LP 801 further includes an analog-to-digital (A/D) data acquisitionsystem (DAS) 850 coupled to one or more electrodes via switch 826 tosample cardiac signals across any pair of desired electrodes. Dataacquisition system 850 is configured to acquire intracardiac electrogramsignals, convert the raw analog data into digital data, and store thedigital data for later processing and/or telemetric transmission to anexternal device 854 (e.g., a programmer, local transceiver, or adiagnostic system analyzer). Data acquisition system 850 is controlledby a control signal 856 from the microcontroller 820.

Microcontroller 820 is coupled to a memory 860 by a suitabledata/address bus. The programmable operating parameters used bymicrocontroller 820 are stored in memory 860 and used to customize theoperation of LP 801 to suit the needs of a particular patient. Suchoperating parameters define, for example, pacing pulse amplitude, pulseduration, electrode polarity, rate, sensitivity, automatic features,arrhythmia detection criteria, and the amplitude, waveshape and vectorof each shocking pulse to be delivered to the patient's heart withineach respective tier of therapy.

The operating parameters of LP 801 may be non-invasively programmed intomemory 860 through a telemetry circuit 864 in telemetric communicationvia communication link 866 with external device 854. Telemetry circuit864 allows intracardiac electrograms and status information relating tothe operation of LP 801 (as contained in microcontroller 820 or memory860) to be sent to external device 854 through communication link 866.

LP 801 can further include magnet detection circuitry (not shown),coupled to microcontroller 820, to detect when a magnet is placed overthe unit. A magnet may be used by a clinician to perform various testfunctions of LP 801 and/or to signal microcontroller 820 that externaldevice 854 is in place to receive or transmit data to microcontroller820 through telemetry circuits 864.

LP 801 can further include one or more physiological sensors 870. Suchsensors are commonly referred to as “rate-responsive” sensors becausethey are typically used to adjust pacing stimulation rates according tothe exercise state of the patient. However, physiological sensor 870 mayfurther be used to detect changes in cardiac output, changes in thephysiological condition of the heart, or diurnal changes in activity(e.g., detecting sleep and wake states). Signals generated byphysiological sensors 870 are passed to microcontroller 820 foranalysis. Microcontroller 820 responds by adjusting the various pacingparameters (such as rate, AV Delay, V-V Delay, etc.) at which the atrialand ventricular pacing pulses are administered. While shown as beingincluded within LP 801, physiological sensor(s) 870 may be external toLP 801, yet still be implanted within or carried by the patient.Examples of physiologic sensors might include sensors that, for example,sense respiration rate, pH of blood, ventricular gradient, activity,position/posture, minute ventilation (MV), and so forth.

A battery 872 provides operating power to all of the components in LP801. Battery 872 is capable of operating at low current drains for longperiods of time, and is capable of providing high-current pulses (forcapacitor charging) when the patient requires a shock pulse (e.g., inexcess of 2 A, at voltages above 2 V, for periods of 10 seconds ormore). Battery 872 also desirably has a predictable dischargecharacteristic so that elective replacement time can be detected. As oneexample, LP 801 employs lithium/silver vanadium oxide batteries.

LP 801 further includes an impedance measuring circuit 874, which can beused for many things, including: lead impedance surveillance during theacute and chronic phases for proper lead positioning or dislodgement;detecting operable electrodes and automatically switching to an operablepair if dislodgement occurs; measuring respiration or minuteventilation; measuring thoracic impedance for determining shockthresholds; detecting when the device has been implanted; measuringstroke volume; and detecting the opening of heart valves; and so forth.Impedance measuring circuit 874 is coupled to switch 826 so that anydesired electrode may be used. In this embodiment LP 801 furtherincludes a shocking circuit 880 coupled to microcontroller 820 by adata/address bus 882.

In some embodiments, the LPs 102 and 104 are configured to beimplantable in any chamber of the heart, namely either atrium (RA, LA)or either ventricle (RV, LV). Furthermore, for dual-chamberconfigurations, multiple LPs may be co-implanted (e.g., one in the RAand one in the RV, one in the RV and one in the coronary sinus proximatethe LV). Certain pacemaker parameters and functions depend on (orassume) knowledge of the chamber in which the pacemaker is implanted(and thus with which the LP is interacting; e.g., pacing and/orsensing). Some non-limiting examples include: sensing sensitivity, anevoked response algorithm, use of AF suppression in a local chamber,blanking & refractory periods, etc. Accordingly, each LP needs to knowan identity of the chamber in which the LP is implanted, and processesmay be implemented to automatically identify a local chamber associatedwith each LP.

Processes for chamber identification may also be applied to subcutaneouspacemakers, ICDs, with leads and the like. A device with one or moreimplanted leads, identification and/or confirmation of the chamber intowhich the lead was implanted could be useful in several pertinentscenarios. For example, for a DR or CRT device, automatic identificationand confirmation could mitigate against the possibility of the clinicianinadvertently placing the V lead into the A port of the implantablemedical device, and vice-versa. As another example, for an SR device,automatic identification of implanted chamber could enable the deviceand/or programmer to select and present the proper subset of pacingmodes (e.g., AAI or VVI), and for the IPG to utilize the proper set ofsettings and algorithms (e.g., V-AutoCapture vs ACap-Confirm, sensingsensitivities, etc.).

While many of the embodiments of the present technology described abovehave been described as being for use with LP type IMDs, embodiments ofthe present technology that are for use in reducing how often a firstreceiver of an IMD wakes up a second receiver of an IMD, in order toreduce power consumption, can also be used with other types of IMDsbesides an LP. Accordingly, unless specifically limited to use with anLP, the claims should not be limited to use with LP type IMDs.

It is to be understood that the subject matter described herein is notlimited in its application to the details of construction and thearrangement of components set forth in the description herein orillustrated in the drawings hereof. The subject matter described hereinis capable of other embodiments and of being practiced or of beingcarried out in various ways. Also, it is to be understood that thephraseology and terminology used herein is for the purpose ofdescription and should not be regarded as limiting. The use of“including,” “comprising,” or “having” and variations thereof herein ismeant to encompass the items listed thereafter and equivalents thereofas well as additional items. Further, it is noted that the term “basedon” as used herein, unless stated otherwise, should be interpreted asmeaning based at least in part on, meaning there can be one or moreadditional factors upon which a decision or the like is made. Forexample, if a decision is based on the results of a comparison, thatdecision can also be based on one or more other factors in addition tobeing based on results of the comparison.

It is to be understood that the above description is intended to beillustrative, and not restrictive. For example, the above-describedembodiments (and/or aspects thereof) may be used in combination witheach other. In addition, many modifications may be made to adapt aparticular situation or material to the teachings of the embodiments ofthe present technology without departing from its scope. While thedimensions, types of materials and coatings described herein areintended to define the parameters of the embodiments of the presenttechnology, they are by no means limiting and are exemplary embodiments.Many other embodiments will be apparent to those of skill in the artupon reviewing the above description. The scope of the embodiments ofthe present technology should, therefore, be determined with referenceto the appended claims, along with the full scope of equivalents towhich such claims are entitled. In the appended claims, the terms“including” and “in which” are used as the plain-English equivalents ofthe respective terms “comprising” and “wherein.” Moreover, in thefollowing claims, the terms “first,” “second,” and “third,” etc. areused merely as labels, and are not intended to impose numericalrequirements on their objects. Further, the limitations of the followingclaims are not written in means—plus-function format and are notintended to be interpreted based on 35 U.S.C. § 112(f), unless and untilsuch claim limitations expressly use the phrase “means for” followed bya statement of function void of further structure.

What is claimed is:
 1. For use by an implantable medical device (IMD), amethod for reducing how often the IMD accepts false messages, the methodcomprising: receiving a message; performing error detection andcorrection on the message; determining a quality measure indicative ofat least one of a quality of the message or a quality of a channel overwhich the message was received; determining whether to reject themessage based on the quality measure, wherein: the IMD is a firstleadless pacemaker (LP) configured to be implanted in a first chamber ofa patient's heart and configured to selectively deliver pacing pules;the message is received by the first LP from a second LP that isconfigured to be implanted in second chamber of a patient's heart andconfigured to at least one of sense intrinsic depolarizations orselectively deliver pacing pulses; the message is indicative of when thesecond LP sensed an intrinsic depolarization or delivered a pacingpulse; and the message, if accepted, is used to trigger a timer of thefirst LP.
 2. The method of claimed 1, wherein the quality measure isindicative of a quality of the message.
 3. The method of claim 2,wherein; the determining the quality measure indicative of the qualityof the message is based on results of the error detection andcorrection; the results of the error detection and correction specifyone of at least two different levels of message quality; and the methodfurther comprises: mapping the results of the error detection andcorrection to one of at least two different numbers; adjusting anaverage message quality based on the number; and comparing the averagemessage quality to one or more thresholds; and the determining whetherto reject the message based on the quality measure comprises determiningwhether to reject the message based on results of the comparing theaverage message quality to the one or more thresholds.
 4. The method ofclaim 3, wherein the mapping the results of the error detection andcorrection to one number of at least two different numbers includes:mapping the results of the error detection and correction to a firstnumber if the results indicated the message was cleanly received withoutany correcting being needed; mapping the results of the error detectionand correction to a second number that is less than the first number ifthe results indicated the message was corrected; and mapping the resultsof the error detection and correction to a third number that is lessthan the second number if the results indicated the message wasuncorrectable.
 5. The method of claim 4, wherein the adjusting theaverage message quality based on the number is performed using anequation Q =(1−1/b)*Q+N*(1/b), where Q is the average message quality, Nis the number to which the results of the error detection and correctionwas mapped, and b a time constant parameter that controls a rate ofchange.
 6. The method of claim 1, wherein the quality measure is basedon whether an amplitude or power of a received signal including themessage is within an expected amplitude or power range.
 7. The method ofclaim 1, wherein the quality measure is based on whether a timing of themessage is within an expected timing range.
 8. The method of claim 1,wherein the determining whether to reject the message comprises:determining that the message should be rejected if the quality measureis below a corresponding lower threshold; determining that the messageshould not be rejected if the quality measure is above a correspondingupper threshold; and if the quality measure is between the correspondinglower and upper thresholds, then determining that the message should berejected if the preceding message was rejected, and determining that themessage should not be rejected if the preceding message was notrejected.
 9. The method of claim 1, wherein the quality measure isindicative of the quality of the channel over which the message wasreceived.
 10. The method of claim 9, further comprising: measuring noiseassociated with the channel over which the message was received; anddetermining the quality of the channel over which the message wasreceived based on the measured noise associated with the channel. 11.The method of claim 9, wherein the determining whether to reject themessage comprises: determining that the message should be rejected ifthe quality measure is below a corresponding lower threshold;determining that the message should not be rejected if the qualitymeasure is above a corresponding upper threshold; and if the qualitymeasure is between the corresponding lower and upper thresholds, thendetermining that the message should be rejected if the preceding messagewas rejected, and determining that the message should not be rejected ifthe preceding message was not rejected.
 12. An implantable medicaldevice (IMD), comprising: at least one receiver configured to receivemessages; and at least one of a processor or controller configure to:perform error detection and correction on a message received by the atleast one receiver; determine a quality measure indicative of at leastone of a quality of the message or a quality of a channel over which themessage was received; and determine whether to reject the message basedon the quality measure, wherein: the IMD is a first leadless pacemaker(LP) configured to be implanted in a first chamber of a patient's heartand configured to selectively deliver pacing pules; the at least onereceiver receives messages from a second LP that is configured to beimplanted in a second chamber of a patient's heart and configured to atleast one of sense intrinsic depolarizations or selectively deliverpacing pulses; at least some of the messages received by the at leastone receiver are indicative of when the second LP sensed an intrinsicdepolarization or delivered a pacing pulse; and at least some of themessage, if accepted, are used to trigger a timer of the first LP. 13.The IMD of claim 12, wherein the quality measure is indicative of aquality of the message.
 14. The IMD of claim 12, wherein the qualitymeasure is indicative of the quality of the channel over which themessage was received.
 15. For use by an implantable medical device(IMD), a method for reducing how often the IMD accepts false messages,the method comprising: receiving a message; performing error detectionand correction on the message; determining a first quality measureindicative of a quality of the message; determining a second qualitymeasure indicative of a quality of a channel over which the message wasreceived; and determining whether to reject the message based on thefirst and second quality measures, wherein: the IMD is a first leadlesspacemaker (LP) configured to be implanted in a first chamber of apatient's heart and configured to selectively deliver pacing pules; theat least one receiver receives messages from a second LP that isconfigured to be implanted in a second chamber of a patient's heart andconfigured to at least one of sense intrinsic depolarizations orselectively deliver pacing pulses; at least some of the messagesreceived by the at least one receiver are indicative of when the secondLP sensed an intrinsic depolarization or delivered a pacing pulse; andat least some of the message, if accepted, are used to trigger a timerof the first LP.
 16. The method of claim 15, wherein the determining thefirst quality measure is based on results of the error detection andcorrection.
 17. The method of claim 15, further comprising; measuringnoise associated with the channel over which the message was received;and determining the second quality measured based on the measured noiseassociated with the channel.
 18. The method of claim 15, whereindetermining whether to reject the message based on the first and secondquality measures comprises: comparing each of the first and secondquality measures to one or more respective thresholds; and determiningwhether to reject the message based on results of the comparing.
 19. Themethod of claim 15, further comprising; producing a combined qualitymeasure based on the first and second quality measures; and whereindetermining whether to reject the message based on the first and secondquality measures comprises comparing the combined quality measure to oneor more thresholds; and determining whether to reject the message basedon results of the comparing.